MUSTANG™ H74939171062070Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729794509), received between Jul 23, 2019 and Sep 21, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (17 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  Reportable based on device analysis completed on (b)(6)2026.It was reported that balloon advancing issue occurred.The 50-60% stenosed target lesion was located in the severely tortuous and mildly calcified arteriovenous fistula. A 6.0 x 200, 75cm Mustang balloon catheter was advanced for dilation. During the procedure, the balloon was fully deflated prior to advancement. However, significant resistance was encountered while advancing the catheter through the sheath. The procedure was completed with another of the same device. There were no patient complications as a result of this event, and the patient's condition post-procedure was stable.However, device analysis revealed a complete circumferential tear located at approximately 53mm distal of the proximal sleeve. A separation of the shaft was located at approximately at the same location of the complete circumferential tear, and the proximal markerband was found to be damaged.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836563 ↗
• MalfunctionJul 30, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091052 ↗
• MalfunctionApr 20, 2026Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01APR2026. IT WAS REPORTED THAT DIFFICULTY ADVANCING OCCURRED. A 6.0 X 200, 75CM MUSTANG WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT SIGNIFICANT RESISTANCE WAS FELT WHEN ADVANCING INTO THE NON-BOSTON SCIENTIFIC SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON PINHOLE LOCATED APPROXIMATELY 4MM DISTAL OF THE DISTAL MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24923378 ↗
• MalfunctionJan 13, 2026Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13JAN2026. IT WAS REPORTED THAT BALLOON FAILED TO INFLATE OCCURRED. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR VESSEL DILATATION. DURING INFLATION AT 23 ATMOSPHERES, THE BALLOON DID NOT EXPAND WELL IN AN AREA OF SEVERE STENOSIS. THE PHYSICIAN WANTED TO CHANGE HIGH PRESSURE BALLOON. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE REVEALED THE PRESENCE OF A BALLOON PINHOLE, WHICH LIKELY CONTRIBUTED TO THE INADEQUATE EXPANSION DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056104 ↗
• MalfunctionDec 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA (AVF). A 6.0 X 200MM,75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE BEING INFLATED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS SEVERELY TORTUOUS AND MODERATELY CALCIFIED. THE BALLOON WAS RUPTURED DURING FIRST INFLATION FOR 30 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892348 ↗
• MalfunctionNov 17, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 6.0 X 200 MM, 75 CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, THE BALLOON RUPTURED UPON INFLATION INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE LESION DETAILS ARE MORE THAN 50% STENOSED, MODERATELY TORTUOUS, AND MODERATELY CALCIFIED. DURING SECOND INFLATION AT 10 ATMOSPHERES FOR 30 SECONDS. THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566017 ↗
• MalfunctionAug 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RADIAL ARTERIOVENOUS FISTULA. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON SECOND INFLATION AT 20 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22824932 ↗
• MalfunctionOct 2, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED SHUNT WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VEIN. A 6.0 X 200, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349911 ↗
• MalfunctionApr 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERTY. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 10 AND 15 ATMOSPHERES FOR 30 AND 45 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201686 ↗
• MalfunctionApr 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X 200, 75CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, WHILE INFLATING THE BALLOON INSIDE THE STENT GRAFT, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113717 ↗
• MalfunctionOct 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERIOVENOUS FISTULA. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST WHILE BLOWING IT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18002609 ↗
• MalfunctionOct 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 25 ATMOSPHERES, THE BALLOON BURST. THE BALLOON SPLIT WHEN THE PHYSICIAN REMOVED THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997047 ↗
• MalfunctionJun 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A LEFT ARTERIOVENOUS FISTULA. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, AFTER THE DEVICE WAS INFLATED MORE THAN THREE TIMES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED THROUGH A NON-BOSTON SCIENTIFIC GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083885 ↗
• MalfunctionJun 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED LEFT ARTERIOVENOUS FISTULA. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, AFTER MORE THREE INFLATIONS ATTEMPTS, THE BALLOON RUPTURED AT 23 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057549 ↗
• MalfunctionMar 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. A 4.0MMX100MMX80CM (4F) STERLING, 4.0 X 100, 75CM MUSTANG, 5.0MMX60MMX80CM (4F) STERLING, 6.0 X 200, 75CM MUSTANG, AND A 6.0 X 100, 75CM MUSTANG BALLOON CATHETERS WERE ADVANCED RESPECTIVELY FOR DILATION. HOWEVER, ON THE FIRST INFLATION, THE BALLOONS RUPTURED. THE DEVICES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495529 ↗
• MalfunctionAug 11, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED ARTERY. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT NOMINAL ATMOSPHERES, THE BALLOON BURST. THE DEVICE WAS SIMPLY PULLED OUT AND NO PATIENT COMPLICATIONS OR INJURIES REPORTED. THE PATIENT CONDITION WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15212872 ↗
• MalfunctionJun 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN THE NORMALLY TORTUOUS AND NORMALLY CALCIFIED RADIAL ARTERY. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED AT NOMINAL PRESSURE AND LEAKED CONTRAST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14738898 ↗
• MalfunctionJan 31, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE IN A LOWER LIMB ANGIOPLASTY. AFTER FLUSHING THE BALLOON SHAFT, THE PHYSICIAN TRIED TO REMOVE THE BALLOON PROTECTIVE SHEATH. HOWEVER, DURING PREPARATION, THE PROTECTIVE SHEATH AND THE BALLOON BROKE OFF FROM THE MAIN SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13404005 ↗
• MalfunctionDec 7, 2020Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18NOV2020. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS FISTULA. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS USED FOR POST DILATATION. HOWEVER, AFTER DILATATION, ANGIOGRAPHY IMAGE REVEALED THAT THE CONTRAST AGENT WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE MO COMPLICATIONS REPORTED AND THE PATIENT WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10963139 ↗
• MalfunctionNov 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THIRD INFLATION AT 16 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9390449 ↗
• InjuryNov 13, 2019Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BALLOON RUPTURE AND DETACHMENT OCCURRED. THE TARGET LESION WAS A SEVERELY CALCIFIED, NON-TORTUOUS, TOTAL OCCLUSION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY(SFA). A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED. ON THE FIRST INFLATION THE BALLOON RUPTURED CIRCUMFERENTIALLY AT A PRESSURE OF 10-12 ATM. WHILE PULLING ON THE BALLOON TO GET IT THROUGH THE SHEATH THE BALLOON CATHETER BROKE INTO TWO PIECES AT THE BALLOON SECTION. THEY ATTEMPTED TO REMOVE THE BROKEN PIECE BUT WERE NOT SUCCESSFUL. DUE TO THE FLOW THE BROKEN PIECE MOVED INTO THE KNEE. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM, WHERE THE BROKEN BALLOON PIECE WAS REMOVED BY ATHERECTOMY IN THE POPLITEAL ARTERY. TWO NON-BSC STENTS WERE THEN PLACED IN THE SFA AND BLOOD FLOW WAS RESTORED. THAT NIGHT THE OUT FLOW VESSELS BELOW THE KNEE THROMBOSED AND THE PATIENT PRESENTED THE FOLLOWING DAY WITH A WHITE LEG DUE TO ACUTE ISCHEMIA. TWO DAYS LATER THE DECISION WAS MADE TO AMPUTATE THE LEG ABOVE THE KNEE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9317844 ↗
• MalfunctionOct 1, 2019Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12SEP2019. IT WAS REPORTED THAT INSERTION DIFFICULTY WAS ENCOUNTERED. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE, BUT THEY ENCOUNTERED DIFFICULTY IN GOING THROUGH THE NON-BSC 5FR SHEATH. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IN THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9141270 ↗
• MalfunctionJul 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0 X 200, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 20 ATMOSPHERES FOR 1-2 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT SERIOUS INJURY OR ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817110 ↗